Minocycline 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Minocycline hydrochloride

Available from:

Crescent Pharma Ltd

ATC code:

J01AA08

INN (International Name):

Minocycline hydrochloride

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010300; GTIN: 5017123494130

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Minocycline Film-coated Tablets
50, 100mg x 28’s (UK)
148x210 (Reel Fed)
50978963
Leaflet for Blisters
1953
T. Hull
19/09/19
* Please note that ONLY Artwork Studio is permitted to make changes to
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approved for print/date
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DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
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FMD info
NA (not a carton)

No

Yes

Details
MINOCYCLINE ALL STRENGTHS FILM-COATED TABLET PIL - UK
Black
Profile
BBBA6347
G. Worth
24/09/2019
148 x 210
7 pt
Accord Barnstaple
n/a
n/a
1
Version 2
01.11.2017
MINOCYCLINE 50MG AND
100MG TABLETS
_Continued top of next column_
_Continued over page_
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor,
pharmacist or nurse.
• This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT MINOCYCLINE TABLETS ARE AND WHAT THEY ARE
USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
MINOCYCLINE TABLETS
3 HOW TO TAKE MINOCYCLINE TABLETS
4
POSSIBLE SIDE EFFECTS
5 HOW TO STORE MINOCYCLINE TABLETS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1
WHAT MINOCYCLINE TABLETS ARE AND WHAT THEY ARE USED FOR
Minocycline belongs to a group of medicines called tetracycline
antibiotics. It
is also known as a b

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Minocycline Tablets BP 100 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 115.85 mg of minocycline hydrochloride
(dihydrate) equivalent
to 100 mg of minocycline.
Excipients with known effect:
Each 100mg tablet contains 35.75 mg lactose.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
The product is presented in the form of buff coloured, biconvex, film
coated tablet,
engraved with company logo on one side and A494 on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minocycline is a broad spectrum antibiotic used for the treatment of
infections caused
by tetracycline-sensitive organisms. Some tetracycline-resistant
strains of
staphylococci are also sensitive.
It is indicated for the treatment of the following infections:
•
Gonorrhoea
•
Non-gonococcal urethritis
•
Prostatitis
•
Moderate to severe acne; use in moderate acne only if topical
treatment is
ineffective, if acne is extensive or hard to reach and if there is a
high risk of
scarring.
•
Acute and chronic bronchitis
•
Bronchiectasis
•
Lung abscess
•
Pneumonia
•
Ear, nose and throat infections
•
Urinary tract infections
•
Pelvic inflammatory disease e.g. salpingitis, oophoritis.
•
Skin and soft tissue infections caused by minocycline sensitive
organisms
•
Ophthalmological infections
•
Nocardiosis
•
Prophylactic treatment of asymptomatic meningococcal carriers
•
Pre and post-operative prophylaxis of infection.
Minocycline should be used only to treat or prevent infections that
are proven
or strongly suspected to be caused by susceptible bacteria.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_ADULTS: _
_ _
Routine antibiotic use: 200 mg daily in divided doses.
Acne: 50 mg twice daily. Treatment should continue for a minimum of
six
weeks.
Gonorrhoea: Adult males: 200 mg initially followed by 100 mg